Exclusive License Agreement [Amendment No. 1] - University of Missouri and Santarus Inc.
AMENDMENT NO. 1 TO EXCLUSIVE LICENSE AGREEMENT BETWEEN THE UNIVERSITY OF MISSOURI AND SANTARUS, INC. This Amendment No. 1 (the "Amendment") to the Exclusive License Agreement dated January 26, 2001 (the "License") between The Curators of the University of Missouri (the "University") and Santarus, Inc. ("Santarus") is made as of February 21, 2003 (the "Effective Date"). RECITALS WHEREAS, the University and Santarus desire to amend certain terms of the License as set forth herein. AGREEMENT NOW, THEREFORE, in consideration of the covenants set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties agree as follows: 1. AMENDMENT OF ARTICLE 15. Article 15 (including Sections 15.1 and 15.2) of the License is hereby amended in its entirety to read as follows: "15. Project Status Reports. *** *** *** *** *** Such progress report shall also include any material deviations from the Schedule of Events attached as Exhibit C." 2. AMENDMENT OF EXHIBIT C. Exhibit C to the License is hereby replaced in its entirety with the revised Schedule of Events set forth on Exhibit A hereto. 3. ACKNOWLEDGMENT. The University acknowledges and agrees that, as of the Effective Date, Santarus has used commercially reasonable efforts to develop and manufacture Licensed Products in accordance with Exhibit C of the License and has to date otherwise satisfied all of the requirements of Section 5.1 of the License. In addition, the University waives any obligation on the part of Santarus arising prior to the Effective Date to *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. <PAGE> adhere to, or notify the University of any material deviations from, the Schedule of Events in the original Exhibit C to the License. 4. MISCELLANEOUS. a. Except for the amendments set forth herein, all other terms and conditions of the License shall remain in full force and effect. b. Capitalized terms used but not otherwise defined herein shall have the meanings assigned to them in the License. c. This Amendment will be interpreted and construed in accordance with the laws of the State of *** , excluding any choice of law rules that would direct the application of the laws of another jurisdiction. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. <PAGE> IN WITNESS WHEREOF, both the University and Santarus have executed this Amendment as of the date set forth above. SANTARUS, INC. By: /s/ Gerald T. Proehl ----------------------------------- Name: Gerald T. Proehl Title: President and CEO THE CURATORS OF THE UNIVERSITY OF MISSOURI By: /s/ Thomas R. Sharpe ----------------------------------- Name: Thomas R. Sharpe, Ph.D. Title: Executive Director Office of Technology & Special Projects <PAGE> Exhibit A Exhibit C Schedule of Events January 26, 2001 Sign definitive licensing agreement Qtr 1 2001 Transfer IND Qtr 2 2001 Develop formulation alternatives, place on stability Begin sublicense negotiations with other PPI company(ies) Qtr 3 2001 Identify and select contract manufacturing organization for omeprazole active pharmaceutical ingredient (API) Identify and select contract manufacturing organization for drug product Qtr 4 2001 Prototype formulation placed on feasibility stability Establish analytical lab for quality control Qtr 1 2002 Determine optimal formulation Qtr 2 2002 Sign sublicense agreement Begin discussions with various pharmaceutical companies on co-development/co-promotion agreement Qtr 3 2002 *** Qtr 4 2002 *** Qtr 1 2003 *** Qtr 2 2003 *** Qtr 3 2003 *** Qtr 4 2003 *** Qtr 1 2004 *** Qtr 2 2004 *** Qtr 3 2005 *** Qtr 4 2005 *** *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.